Adverse Event Reporting
| VAERS ID | 1401073 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | |
| Onset | |
| Condition |
Symptoms
- Atrial fibrillation
- Disease recurrence
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: AFib (last episode)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
recurrence of atrial fibrillation episode 5 days after the first dose and atrial fibrillation recurrence 7 days after the second dose of vaccine.
last episode April 2020; recurrence of atrial fibrillation episode 5 days after the first dose and atrial fibrillation recurrence 7 days after the second dose of vaccine.
last episode April 2020; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB, regulatory authority number: IT-MINISAL02-734872.
A 71-year-old male patient received BNT162B2 (COVID 19 COMIRNATY VACCINE (PFIZER)), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 08:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation.
Medical history included atrial fibrillation (AFib) wherein last episode was on Apr2020; unknown if ongoing.
The patient's concomitant medications were not reported.
The patient experienced recurrence of atrial fibrillation episode on an unspecified date 5 days after the first dose; and atrial fibrillation recurrence on 22May2021 08:00, 7 days after the second dose of vaccine.
Patient went to the emergency room for the adverse event where they have performed electric cardioversion.
The events were assessed as serious: medically significant.
The outcome of events was recovering.
Sender Comment:26May2021 Regulatory Authority: this reporting form is updated from NON SEVERE to SEVERE as the suspected adverse reaction described represents a clinically relevant event predicted from the IME list.
26May2021 Regulatory authority requests for follow-up information from the reporter regarding clinical documentation and lot number.
On hold.
No follow-up attempts are possible.
No further information is expected.
Information on lot and batch numbers cannot be obtained.
; Reporter's Comments: Reaction time: 08:00 - Posted by VigiCovid19-tab